Global Radiopharmaceutical CDMO Market 2025 – 2034

Reports Description

As per the Radiopharmaceutical CDMO Market analysis conducted by the CMI Team, the global Radiopharmaceutical CDMO Market is expected to record a CAGR of 9.3% from 2025 to 2034. In 2025, the market size is projected to reach a valuation of USD 3.1 Billion. By 2034, the valuation is anticipated to reach USD 7.2 Billion.

Overview

Sustainability, precision, and compliance also represent areas of convergence in the Radiopharmaceutical CDMO Market when used in pharmaceutical and biotechnology applications. The global ESG movement has prompted CDMOs to concentrate on green manufacturing methods including energy-saving cyclotrons, shielding materials that can be recycled, and streamlined radiolabeling procedures that can produce the least amount of radioactive waste. However, current facility design approaches focus on operational safety, reliability and easy-to-use digital interfaces to enhance accuracy and risk mitigation in high throughput radiopharmaceutical manufacturing.

Additionally, IoT-based monitoring, automated quality control, and batch reporting on clouds are enhancing transparency, traceability, and regulatory adherence. These innovations do not only guarantee compliance with strict standards of the FDA, EMA, and IAEA, but also provide confidence to the pharmaceutical customers, medical professionals, and authorities. Ensuring sustainability and incorporating the latest technology, CDMOs acquire a better image, win long-term contracts, and become a competitive force in the global radiopharmaceutical supply chain.

Key Growth Drivers

The Radiopharmaceutical CDMO Market Trends have tremendous growth opportunities due to several reasons:

• Increasing Regulations: Regulations in the pharmaceuticals and diagnostics are becoming stricter with the international agencies and governments demanding more precision, reproducibility, and adherence. Radiopharmaceutical CDMOs are highly important in that they provide GMP-qualified facilities, qualified processes, and compliance to international standards. This guarantees secure, conforming and scalable drug development. An example of this is that in August 2025, Former FDA Commissioner Stephen Hahn was made CEO of Nucleus RadioPharma, a U.S.-based radiopharma CDMO, which further makes the case of an industry that is seeking greater regulatory prowess at the top.

• ESG Agenda (Sustainability Focus): The global ESG trend is influencing radiopharmaceutical production, which is becoming energy-efficient, has components that can be recycled, and is being produced in ways that are more environmentally friendly. To meet the expectations of clients and international sustainability objectives, CDOMS are making investments in the upgrading of their facilities and environmentally sustainable supply chain solutions. In April 2025, Medi-Radiopharma opened a new FDA- and EMA-approved plant that could make 3.5 million vials per year, with sustainable design and operational efficiency to serve the market around the world by having less environmental impact.

• Automation & Digitalization: Automation, IoT, and AI-driven monitoring systems are becoming common among radiopharmaceutical CDMOs in order to enhance efficiency, accuracy and traceability. Digitalization makes human error less and acceleratesdevelopment cycles and regulatory compliance in high volume environments. Client trust is also enhanced by the incorporation of cloud-based reporting and smart manufacturing tools. In March 2025, A new AI-based Digital Formulator plus the Self-Driving Datafactory tableting Datafactory that came to pharma R&D demonstrates how automation and predictive modeling can help to shorten drug development time cycles – a technology trend that may soon affect radiopharma CDMOs.

Key Threats  

The Radiopharmaceutical CDMO Market has several primary threats that will influence its profitability and future development. Some of the threats are:

• High Capital Investment: Radiopharmaceutical CDMOs need significant initial investment in cyclotrons, nuclear reactors, GMP-accredited cleanrooms and highly specialized facilities. This type of business model is prohibitive to smaller players due to the purchase, installation, regulatory validation and isotope supply expenses. This is because this high barrier to entry prevents the involvement of the middle-sized companies and postpones the entry into the developing economies despite the long-term benefits of outsourcing.

• The requirements are sophisticated maintenance and training: Manufacturing radiopharmaceutical systems requires a high level of skilled staff who have been trained in the field of nuclear safety, handling of isotopes, and regulatory compliance. Hiring, developing, and retaining these specialized talents may be resource-consuming, especially in emerging markets where there is a scarcity of expertise. Also, preservation of GMP-grade facilities with radiological protection is more operationally complex, making it more likely that compliance is compromised and small institutions are constrained in scale.

Opportunities

• Advancements in Green & Sustainable Radiochemistry: There are opportunities for CDMOs to adopt more sustainable methods for Isotope production using low-energy cyclotrons, consumables with more recyclable components and technologies for radioactive waste reduction (waste management innovations). These methods offer cost-effective ways to operate and decrease the amount of waste without negative impacts to the environment and support goals for sustainable global Green Chemistry. Companies working to support eco-friendly supply chains for isotopes will likely outperform their competitors.

• Expansion in Emerging Markets: Asia-Pacific, Latin America, and the Middle East are emerging regions where there is a lot of infrastructure growth within the sectors of nuclear medicine and healthcare. These regions and markets are increasing their demand for nuclear medicine for diagnostics, cardiology imaging, and targeted radionuclide therapies. Aligning regulatory frameworks with global GMP standards and the sustainable production of isotopes will allow for a gross expansion of CDMOs and capture untapped demand.

Category Wise Insights

By Application

• Diagnostic Radiopharmaceuticals: Radiopharmaceuticals designed for these purposes are predominantly used for disease detection in the early stages using PET and SPECT imaging. They command the market because of their numerous applications in the diagnostics of oncology, cardiology, and neurology. Accurately and reproducibly, these imaging techniques render the gold standard for non-invasive imaging. Further investment in molecular imaging within the healthcare sector raises their market prominence. Meeting the market demand for these imaging techniques in early detection personal medicine CDMOs, under GMP standards, and in conjunction with the healthcare sector, provides critical support in the ready supply of these imaging techniques. 

• Therapeutic Radiopharmaceuticals: There is global consensus on the use of targeted radiopharmaceuticals and radionuclide therapies in the treatment of diseases. Research and commercialization on Lutetium-177 and Actinium-225 for the treatment of cancer are actively being pursued. Unlike conventional therapy, these targeted therapies significantly impact the side effects of treatment by delivering radiation to the diseased cells. The emergence of theragnostics rapidly augments the integration of diagnostics and treatment. CDMOs surplus radiopharmaceuticals and support biopharma companies with formulation, scale-up, and regulatory compliance. This is one of the most rapidly advancing areas within radiopharmaceuticals.

By Radioisotope Type

• Technetium-99m: Each year, over 25 million diagnostic procedures are performed using this radioisotope, which is the basis of nuclear medicine. Its diagnostic quality, half-life, and imaging versatility make it the most widely used radionuclide globally. Hospitals depend on its steady supply for imaging procedures related to cancer and the cardiovascular system. Reliance on CDMOs for stability and scale is expanding due to supply challenges, as CDMOs ensure quality production and distribution. Tc-99m is expected to remain the most used radioisotope for the foreseeable future, despite competition from other newly developed isotopes.

• Fluorine-18: There are over 42 million PET scans done with PET imaging, most of which are head and neck cancer imaging and brain scans using Fluorine-18. Its popularity is due to the resolution of images it produces. Fluorine-18’s half-life, however, complicates the distribution of the radionuclide. Therefore, the demand for CDMOs to address regulatory challenges associated with short-lived isotopes is on the rise. As the demand for PET scans continues to increase, Fluorine-18 is expected to be one of the most rapidly growing radioisotopes used in nuclear medicine.

• Lutetium-177: This radioisotope is applied as a primary treatment option in cancer of the prostate and neuroendocrine system due to its popularity in cancer treatment, which is driving the growth for therapeutic radiopharmaceuticals. CDMOs are increasing the supply chain and manufacturing capacity in response to the growth in demand for this radioisotope. Its targeted therapy with minimal toxicity is the primary driver for its growing demand. This radioisotope will soon dominate the therapeutic space due to its approvals and clinical use.

• Gallium-68: Primarily utilized in PET imaging for the detection of certain cancers, Gallium-68 is favored for its generator-based supply, which permits on-demand access. Approximately 90% of Ga-68 supply is used for oncology. Ga-68 tracers are becoming more common in oncology applications and CDMOs are aiding in developing clinical trials and scaling up Ga-68 tracers. As PET imaging becomes more prevalent, so does the demand for Ga-68, which is further fueled by its growth prospects in combination with Lu-177 for theranostics.

• Actinium-225: This alpha-emitting radioisotope of actinium is one of the few radioisotopes rapidly growing its applications with advanced radiotherapy for cancer. It provides highly focused and potent radiation therapy even against some of the more therapy-resistant cancers. Unlike the other isotopes under review, which are more established, the limited supply of Ac-225 creates an opportunity for more CDMOs to develop and expand their advanced therapy radiopharmaceutical offerings. Consequently, the relative market share of Ac-225 is smaller than the established isotopes but growing quickly. CDMOs will continue to be the entity expected to create reliable and scalable production lines. 

• Others: Finally, the remaining isotopes which are less in demand include I-131, Cu-64, and Y-90, among others, include both therapeutic and diagnostic applications across a wide array of conditions. They promote the diversity and resilience of the radiopharmaceutical market. In contrast to the larger volume isotopes, the CDMOs cater to these in smaller volumes but with more precise control. The growth of these isotopes is dependent on research and niche therapeutic demand.

By Source of Manufacturing

• Nuclear Reactors: Nuclear reactors constitute an elegant source for large-scale production of the medically important diagnostic isotopes. They are particularly important for the supply of molybdenum-99, which is the parent of Tc-99m used for the most common nuclear medicine imaging procedures. Aging infrastructure and risks of complete shutdowns, however, cannot be overlooked in projecting the security of supply. CDMOs fill the gaps in steady access and regulatory compliance for the reactor supplied isotopes. Efforts to stabilize supply are leak sealing with infrastructure modernization and clinical demand expansion. Reactors’ supply is limited; however, they are still invaluable for the world’s isotope supply.

• Cyclotrons: The production of the short-lived isotopes like F-18 and Ga-68 is the intended use of most currently operating cyclotrons. Their clinical value is hard to measure but with the currently unpredictable geopolitical environment, they raise the value of local access. CDMOs also increase cyclotron investments in response to hospital and nursing demand for isotopes. The current trend toward mini-cyclotrons is also enabling in-hospital production. This source is expected to outpace reactors in the supply of isotopes due to their organizational flexibility.

By Therapeutic Area

• Oncology: The oncology sector holds the greatest share of the radiopharmaceutical market. The role of radiopharmaceuticals in the imaging, staging, and specialized treatment of cancer is invaluable. The rise of oncology theranostics further strengthens this field. CDMOs provide the capacity to produce radiopharmaceuticals and align them with regulations for oncology and oncology-related applications. The growing incidence of cancer around the world is the primary reason for the continuous growth of this market. It is also the primary reason for the continuous growth of this market. As the primary driver of innovative and strategic investments, this market continues to shape therapeutic developments.  

• Neurological Disorders: The neurological applications of radiopharmaceuticals, especially in imaging for Alzheimer’s and Parkinson’s, are expanding rapidly. The early detection and the monitoring of degenerative neurological disorders are made possible with the use of radiotracers. CDMOs, in collaboration with pharmaceutical companies, are expanding the tracer development for neurodegenerative diseases. As the population ages and the clinical use of these tracers increases, the demand for these radiopharmaceuticals is expected to rise. Neurology-related radiopharmaceuticals also support research in clinical trials for disorders of the central nervous system. Thus, this market segment holds considerable long-term growth potential.  

• Cardiovascular Disorders: The use of radiopharmaceuticals for imaging the heart and diagnosing heart-related conditions is another application that remains constant. Myocardial perfusion imaging and facilitating the diagnosis and monitoring of coronary artery disease are done with the use of Tc-99m fission products. The demand consistency is facilitated by CDMOs and ensured by the mortality rates associated with cardiovascular disorders. Value is also added to these applications by the development of new imaging tracers.

• Other Areas: In addition to oncology, neurology, and cardiology, radiopharmaceuticals are used to image kidneys, infections, and inflammation. These specialized uses contribute to meeting the complete healthcare spectrum. CDMOs handle these smaller but essential product lines to keep supply chains operational. They assist in achieving targeted therapeutic strategies in various disciplines. Regulatory and research aid facilitates consistent growth for this segment. While the contribution may be minor compared to other segments, it significantly enhances the resilience of the entire market.

By End-user

• Creating Demand for CDMO Services: Pharmaceutical companies rely on CDMOs for formulation, clinical trial assistance, and GMP manufacturing. The development of CDMOs- outsourced radiopharmaceuticals is done to ensure cost management and maintain compliance. CDMOs maintain scalability throughout the preclinical to post-commercial phases. Collaboration with pharma companies enhances the speed of innovation and go-to-market strategy. This sector continues to be the largest customer base and demand for CDMO services.

• Innovation and Research: Research institutions rely on CDMOs for isotope provision, small-scale radiopharmaceutical manufacturing, and regulatory support. Innovations advanced by CDMO collaboration enable clinical research and assist with early-stage discovery. International expansion of academic research is supported by new grants and funding. CDMOs positioned themselves as enablers of this research through the provision of compliance support and infrastructure. Consistent innovative research is critical to the advancement of the industry.

• Support from CDMO: Consistent and compliant supply of radiopharmaceuticals for both diagnostics and therapy is by hospitals. As theranostics continues to expand, hospitals will rely on CDMO partnerships even more. CDMOs ensure the just-in-time delivery of short-lived isotopes, which ensures delivery to CDMO-dependent hospitals. This segment ensures that CDM hospitals receive consistent and predictable revenue for their services.

• Others: End-users include Contract Research Organizations (CROs), diagnostic laboratories, and industrial research entities who utilize radiopharmaceuticals for testing, contract services, and specialized applications. Customized manufacturing and supply chain management offered by Contract Development and Manufacturing Organizations (CDMOs) fulfill their needs. While this segment may be smaller in scale, it contributes to the overall diversity of the market. The demand for specialized tracers provides ample opportunities for growth. This segment enhances the ecosystem of CDMO clients.

Historical Context

Radiopharmaceutical CDMO Market Major players are improving growth by investing in more efficient manufacturing systems, ecological design, and advanced automation. To have accurate, scalable and sustainable operations, companies are introducing environmentally friendly and efficient equipment that is easy to recycle, smart software, and energy saving machines. Product products are being diversified with high throughput, miniaturized and customized products to meet the needs of pharmaceutical, diagnostic, and therapeutic applications.

Companies are also progressing in green production technology that uses a lesser amount of chemicals and waste. Active studies in the automated synthesis, isotope labeling and sustainable production techniques are helping to improve the preparation and supply of radiopharmaceuticals in a safer, faster and more dependable way without violating the high standards of the international standards.

Impact of Latest Tariff Policies

The Radiopharmaceutical CDMO Market is being influenced by the current international trade and regulatory policies with the U.S., China, and the European Union reforming their import-export legislation that affects the supply and price of radioisotopes, specialized laboratory equipment, and production parts. Reliance on foreign cyclotrons, nuclear reactors, shielding materials, and sophisticated synthesis modules has added to the cost of production, especially for those manufacturers who have their suppliers in Europe and Asia. Small and mid-sized CDMOs with a small and undiversified chain of supply are the ones who experience these extra costs most intensely.

Major multinational CDMOs are in turn counterbalancing the effects of trade policies by offshoring procurement and production to low-tariff zones in the Southeast, Eastern Europe, and Latin America. They are also embracing automation, process control using AI and radiopharmaceutical production technologies that run on low energy to streamline operations and to counter tariff-related costs.

Smaller companies, though, are more at a disadvantage because of the variable costs of transportation, low supplier influence, and less access to capital in order to invest in technologies. The pressures are increasing the rate of consolidation in industries and consolidating forces of financially sound global CDMOs with diversified supply chains, sophisticated research and development, and scalable production infrastructure in the market.

Report Scope

Regional Perspective

The Radiopharmaceutical CDMO Market can be divided across different regions such as North America, Europe, Asia-Pacific, and LAMEA. This is a cursory overview of each region:

North America: North America is a mature and well-developed market for radiopharmaceutical CDMO services, with a rich pharmaceutical R&D base, developed nuclear medicine infrastructure, and solid reimbursement frameworks. The United States leads the region with world-class hospitals, a vast clinical trials landscape, and stringent FDA regulations driving the need for GMP-compliant CDMO and dependable isotope supply chains. U.S. large biotech and pharma companies often outsource the development and commercial manufacturing to CDMOs to address the complexity and the scale of the production for the U.S. market. Canada is experiencing steady growth driven by academic research centres, an expanding nuclear medicine community, and government support for healthcare innovation, all of which encourage local CDMO partnerships. Investments in cyclotron capacity, short-lived isotope supply chain logistics, and sustainability have reinforced regional ecosystem growth. In summary, North America is the largest revenue contributor and the radiopharmaceutical CDMO services innovation leader.

• United States Radiopharmaceutical CDMO Market: The U.S. is the dominant market with widespread use across clinical, research, and commercial channels; the demand is driven by robust oncology pipelines, theranostics programs, and large private and public R&D expenditures.

• Canada Radiopharmaceutical CDMO Market: Research hospitals, regional cyclotron centers, and expanding partnerships among universities and industries for tracer development and clinical supply are contributing factors to the steady growth of Canada’s market.

Europe: Europe accounts for a well-developed and strict CDMO market for radiopharmaceuticals, with Germany, the UK, and France being the most active. A robust public and private investment in nuclear medicine, well-developed hospital networks, and harmonized expectations within the EMA framework influence CDMOs to provide high-quality compliant manufacturing and analytical services. Germany excels in manufacturing, reactor and cyclotron construction, and active participation in clinical trials, while UK life-sciences hubs and translational research increase the demand for CDMO partnerships. France contributes to regional growth with a vibrant pharmaceutical industry and public incentives for innovation in healthcare. European CDMOs prioritize sustainability, traceability, and modular production to satisfy regulatory and ESG criteria.

• Germany Radiopharmaceutical CDMO Market: Germany has a well-established clinical research and radiopharma production environment with automation and a resilient isotope supply.

• United Kingdom Radiopharmaceutical CDMO Market: The UK market has a vibrant tracer R&D and theranostics sector which provides the foundation for expanding CDMO partnerships to facilitate translation and commercialization.

• France Radiopharmaceutical CDMO Market: France’s benefit comes from the combination of solid public programs that enhance nuclear medicine capacity and a strong CDMO-supportive pharmaceutical industry.

Asia-Pacific: Asia-Pacific is the most promising regional market for radiopharmaceutical CDMOs due to the fast pace of healthcare modernization, increased cancer workload, the development of diagnostic networks, and increased budgets in research and development. China is the biggest consumer of APAC with massive investments in cyclotrons, hospital networks and home CDMOs that are increasing capacity to fulfill local demand and decrease reliance on imports. A rising pace of adoption is being observed in India with the modernization of hospitals and research centres, growth in the scale of domestic firms in the production of cyclotrons and radiopharmaceuticals and regulations within the nation are being modified to facilitate clinical development. Japan continues to be a mature market with an emphasis on high-precision and high-quality manufacturing and high-quality theranostics research whereas South Korea is rapidly developing based on innovation clusters and industry-academic collaborations. APAC, as a whole, has a blend of a large market, cost benefits and aligned policy that can be considered the most important engine of growth in the world.

• China Radiopharmaceutical CDMO Market: China is the regional leader with fast growth in isotope production, hospital adoption, and local CDMO capacity to cover the large patient base.

• India Radiopharmaceutical CDMO Market: developing rapidly, India can be characterized by increasing healthcare expenditures, increasing domestic production, and expanding clinical research.

• Japan Radiopharmaceutical CDMO Market: Japan is a mature and quality-based country, and its precision radiopharmacy and theranostics development are well-developed.

LAMEA (Latin America, Middle East & Africa): LAMEA is a developing region with high potential, but one that is not as mature across the countries; adoption is enabled by focused government policies, foreign collaborations as well as healthcare infrastructure investments. Brazil leads in Latin America, with an expanding number of hospitals, oncology services, and developing collaborations with CDMOs to localize the supply of tracers. Saudi Arabia is quickly establishing capacity through national diversification initiatives (e.g., Vision 2030), investing in hi-tech healthcare developments and inviting foreign investors to produce radiopharmas and train local staff. South Africa is a regional centre of nuclear medicine services and clinical research, with an increasing focus on collaborations to improve access to isotopes and CDMO expertise across Sub-Saharan Africa. Infrastructure and regulatory challenges in some regions notwithstanding, LAMEA presents appealing long-term incentives to CDMOs eager to invest in localized production and capacity-building solutions as well as supply-chain solutions.

• Brazil Radiopharmaceutical CDMO Market: Brazil is the most developed Latin American market, and it expands due to the modernization of hospitals, oncology services, and collaborations in regions CDMO.

• Saudi Arabia Radiopharmaceutical CDMO Market: Saudi Arabia is undertaking major investments in healthcare and radiopharma capacity as a part of the economic diversification and strategic health programs.

• South Africa Radiopharmaceutical CDMO Market: South Africa functions as a regional point of entry that has developed nuclear medicine services and potential CDMO-public partnering.

Key Developments

• In October 2024, SpectronRx signed a binding agreement to build its first European radiolabeling plant at the Belgian Nuclear Research Center (SCK CEN) in Mol, with operations set to begin in early 2025 pending certification; the facility will primarily produce actinium-225-based radiopharmaceuticals, which are increasingly in demand for targeted cancer therapies across Europe, addressing supply shortages and supporting a pipeline of EMA-backed treatments. Leveraging its proprietary method for producing Ac-225 from multiple source elements, SpectronRx aims to manufacture these drugs at scale, further expanding on its global operations, which currently span five sites in 29 countries and involve collaborations with over 31 pharmaceutical firms and a workforce of about 150 employees.

Leading Players

The Radiopharmaceutical CDMO Market is highly competitive, with a large number of product providers globally. Some of the key players in the market include:

• NorthStar Medical Radioisotopes
• Eckert & Ziegler
• ITM Isotope Technologies München SE
• Curium Pharma
• Cardinal Health
• SOFIE
• PharmaLogic
• Monrol (Eczacıbaşı‑Monrol)
• SpectronRx
• Ionetix Corporation
• Minerva Imaging
• Seibersdorf Labor GmbH
• Evergreen Theragnostics Inc.
• Global Medical Solutions
• GBI Biomanufacturing
• Others

Radiopharmaceutical CDMO Market is experiencing strong growth in the world, as the demand for targeted therapies, precision diagnostics, and solutions of nuclear medicine is increasing. Contract development and manufacturing organizations (CDMOs) are now paying more attention towards offering end-to-end services—this is renting out the isotope production and formulations, from quality control and regulatory compliance, to pharmaceutical and biotechnology companies across the globe. Higher scalability, purity, and cost effectiveness are being guaranteed by the combination of automated synthesis platforms, process monitoring by AI and GMP certified facilities.

Sustainability activities are also on the rise, including low-waste cyclotron operation, efficient use of reactors, and environmentally friendly packaging. Collaborations between CDMOs, institutions of higher learning, and health care facilities are facilitating earlier clinical translation of new radiopharmaceuticals in fields such as oncology and neurological therapies. Combined, these advances are making CDMOs important innovation enablers in personalized medicine and global radiopharmaceutical supply chains.

The Radiopharmaceutical CDMO Market is segmented as follows:

By Application

• Diagnostic Radiopharmaceuticals
• Therapeutic Radiopharmaceuticals

By Radioisotope Type

• Technetium-99m
• Fluorine-18
• Lutetium-177
• Gallium-68
• Actinium-225
• Others

By Source of Manufacturing

• Nuclear Reactors
• Cyclotrons

By Therapeutic Area

• Oncology
• Neurological Disorders
• Cardiovascular Disorders
• Others

By End-user

• Pharmaceutical & Biotechnology Companies
• Academic & Research Institutions
• Hospitals & Nuclear Medicine Centers
• Others

Regional Coverage:

North America

• U.S.
• Canada
• Mexico
• Rest of North America

Europe

• Germany
• France
• U.K.
• Russia
• Italy
• Spain
• Netherlands
• Rest of Europe

Asia Pacific

• China
• Japan
• India
• New Zealand
• Australia
• South Korea
• Taiwan
• Rest of Asia Pacific

The Middle East & Africa

• Saudi Arabia
• UAE
• Egypt
• Kuwait
• South Africa
• Rest of the Middle East & Africa

Latin America

• Brazil
• Argentina
• Rest of Latin America